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    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
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    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
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    <deviceName>ALINITY M HIV-1 DBS ASF</deviceName>
    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08N45-04B</reference>
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    <lastUpdated>2026-07-16T04:24:06.744Z</lastUpdated>
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    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
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    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
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    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N46-072</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>Alinity m</tradeName>
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    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040403</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N43-072</reference>
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    <lastUpdated>2026-07-16T04:24:00.229Z</lastUpdated>
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    <deviceName>ALINITY M BKV</deviceName>
    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
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    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N85-070</reference>
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    <lastUpdated>2026-07-16T04:23:59.433Z</lastUpdated>
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    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Alinity m</tradeName>
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    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
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    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
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    <emdnDescription>VARICELLA ZOSTER  - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N61-080</reference>
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    <tradeName>Alinity m</tradeName>
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    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-16T04:23:48.218Z</lastUpdated>
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    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N78-080</reference>
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    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>Alinity m</tradeName>
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    <manufacturerName>Abbott Molecular Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017776</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>09N15-080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:23:46.165Z</lastUpdated>
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